At the end of FDA's establishment inspection, the investigator makes "observations” of instances where it appears the firm does not conform to a regulatory requirement. You are warned that if you do not correct the problems, FDA may take further legal action. How you respond to FDA from that point on plays a critical role in your future with FDA. Inspectional observations show what problems you have had in the past, where you still have problems and whether or not you know how to effectively respond to inspectional observations. In FDA's mind, the question is, "Do you get it?”
Webinar on FDA’s “483” – Inspectional Observations by Global Compliance Trainings
10 March 2014, michigan, United States
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online, michigan, United States
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